Magnetic Resonance Imaging (MRI) in Predicting Response to Sunitinib Malate in Patients With Locally Advanced or Metastatic Kidney Cancer
Summary
Rationale: Diagnostic procedures, such as MRI, may help doctors predict a patient's response to treatment and help plan the best treatment.
Purpose: This clinical trial is studying MRI in predicting response to sunitinib malate in patients with locally advanced or metastatic kidney cancer.
Description
Primary Objectives:
I. To correlate tumor vascular permeability by DCE-MRI with clinical outcome for patients treated with sunitinib (PFS).
II. To correlate genetic and histologic characteristics of the primary tumor with vascular permeability by DCE-MRI.
Secondary Objectives:
I. To correlate genetic and histologic characteristics of the primary tumor with clinical outcome for patients treated with sunitinib.
II. Samples will be collected for potential future exploratory analyses of pharmacokinetic and pharmacogenomic parameters.
Outline: Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days in the absence of disease progression or unacceptable toxicity.
Patients undergo dynamic contrast-enhanced MRI at baseline and after the first 4 weeks of sunitinib malate.
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Conditions
Renal Cell Carcinoma
Intervention
mutation analysis, pharmacological study, dynamic contrast-enhanced magnetic resonance imaging, sunitinib malate, immunohistochemistry staining method, laboratory biomarker analysis
Location
Abramson Cancer Center of The University of Pennsylvania
Philadelphia
Pennsylvania
United States
19104
Status
Recruiting
Source
Abramson Cancer Center of the University of Pennsylvania
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01026337
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:17:31-0400
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Medical and Biotech [MESH] Definitions
Electron Spin Resonance Spectroscopy
A technique applicable to the wide variety of substances which exhibit paramagnetism because of the magnetic moments of unpaired electrons. The spectra are useful for detection and identification, for determination of electron structure, for study of interactions between molecules, and for measurement of nuclear spins and moments. (From McGraw-Hill Encyclopedia of Science and Technology, 7th edition) Electron nuclear double resonance (ENDOR) spectroscopy is a variant of the technique which can give enhanced resolution. Electron spin resonance analysis can now be used in vivo, including imaging applications such as MAGNETIC RESONANCE IMAGING.
Contrast Media
Substances used to allow enhanced visualization of tissues.
Kinesics
Systematic study of the body and the use of its static and dynamic position as a means of communication.
Spatio-temporal Analysis
Techniques which study entities using their topological, geometric, or geographic properties and include the dimension of time in the analysis.
Matched-pair Analysis
A type of analysis in which subjects in a study group and a comparison group are made comparable with respect to extraneous factors by individually pairing study subjects with the comparison group subjects (e.g., age-matched controls).
